NALIRIFOX Demonstrates Consistent Safety in Metastatic Pancreatic Cancer

Patients with metastatic pancreatic ductal adenocarcinoma who receive NALIRIFOX tend to have more gastrointestinal toxicity while nab-paclitaxel/gemcitabine results in more cytopenias, according to an expert from University of California, Los Angeles.

The safety profile of first-line liposomal irinotecan (Onivyde) plus 5 fluorouracil/leucovorin and oxaliplatin (NALIRIFOX) in patients with metastatic pancreatic ductal adenocarcinoma was consistent with those previously reported findings, according to Zev A. Wainberg, MD, regarding the phase 3 NAPOLI-3 study (NCT04083235).

In an interview with CancerNetwork®, lead author Wainberg, a professor of medicine at the University of California, Los Angeles (UCLA) and co-director of the UCLA Gastrointestinal Oncology Program, discussed the safety of NALIRIFOX compared with gemcitabine plus nab-paclitaxel from the NAPOLI-3 study, which was presented at the 2023 Gastrointestinal Cancers Symposium.

In NAPOLI-3, common grade 3/4 treatment-emergent adverse effects observed in patients receiving NALIRIFOX vs those receiving gemcitabine plus nab-paclitaxel, respectively, included diarrhea (20.3% vs 4.5%), nausea (11.9% vs 2.6%), hypokalemia (15.1% vs 4.0%), anemia (10.5% vs 17.4%), and neutropenia (14.1% vs 24.5%).

Wainberg also discussed the trial’s limitations, which included the fact that it was not placebo controlled.


Most of the safety data are consistent with what we knew of these regimens. The NALIRIFOX had more GI toxicity than gemcitabine/nab-paclitaxel, and the gemcitabine/nab-paclitaxel had more cytopenias than NALIRIFOX. However, we were pleasantly pleased by a low rate of peripheral neuropathy in our study which, in the NALIRIFOX arm, indicated a lower dose of the cumulative oxaliplatin usage and that had important implications. Those were some of the main safety findings in the NAPOLI-3 trial.

There are always limitations to a study. It wasn’t placebo-controlled. There are certainly biases about which patients [should br included.] But this study took a really bread and butter group of patients, which is newly diagnosed metastatic pancreatic cancer, in centers all around the world, not in academic centers and community centers. There was not a huge number of differences in this kind of study than what we would expect in the real world.


Wainberg ZA, Melisi D, Macarulla T, et al. NAPOLI-3: A randomized, open-label phase 3 study of liposomal irinotecan + 5-fluorouracil/leucovorin + oxaliplatin (NALIRIFOX) versus nab-paclitaxel + gemcitabine in treatment-naïve patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). J Clin Oncol. 2023;41(suppl 4):LBA661. doi:10.1200/JCO.2023.41.3_suppl.LBA661

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